Randomized comparison of oral valacyclovir and intravenous ganciclovir for prevention of cytomegalovirus disease after allogeneic bone marrow transplantation

Clin Infect Dis. 2003 Mar 15;36(6):749-58. doi: 10.1086/367836. Epub 2003 Mar 3.

Abstract

In this multicenter, randomized study, cytomegalovirus (CMV)-seropositive patients who received an allogeneic bone marrow transplant were provided high-dose intravenous acyclovir (500 mg/m(2) q8h) from the day of transplantation until engraftment. The patients were then randomly assigned to receive either oral valacyclovir, 2 g q.i.d. (n=83), or intravenous ganciclovir, 5 mg/kg q12h for 1 week, then 6 mg/kg once daily for 5 days per week (n=85), until day 100 after transplantation. CMV infection occurred in 12% of the patients who received valacyclovir and in 19% of the patients who received ganciclovir (hazard ratio [HR], 1.042; 95% confidence interval [CI], 0.391-2.778; P=.934). CMV disease developed in only 2 patients who received valacyclovir and in 1 patient who received ganciclovir (HR, 1.943; 95% CI, 0.176-21.44; P=.588). Oral valacyclovir can be an effective alternative to intravenous ganciclovir for prophylaxis of CMV disease after bone marrow transplantation.

Publication types

  • Clinical Trial
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Acyclovir / adverse effects
  • Acyclovir / analogs & derivatives*
  • Acyclovir / therapeutic use*
  • Administration, Oral
  • Adolescent
  • Adult
  • Aged
  • Antiviral Agents / adverse effects
  • Antiviral Agents / therapeutic use*
  • Bacterial Infections / mortality
  • Bone Marrow Transplantation*
  • Cytomegalovirus / drug effects
  • Cytomegalovirus Infections / mortality
  • Cytomegalovirus Infections / prevention & control*
  • Female
  • Ganciclovir / adverse effects
  • Ganciclovir / therapeutic use*
  • Humans
  • Injections, Intravenous
  • Male
  • Microbial Sensitivity Tests
  • Middle Aged
  • Mycoses / mortality
  • Sepsis / mortality
  • Survival Analysis
  • Transplantation, Homologous
  • Valacyclovir
  • Valine / adverse effects
  • Valine / analogs & derivatives*
  • Valine / therapeutic use*

Substances

  • Antiviral Agents
  • Valine
  • Valacyclovir
  • Ganciclovir
  • Acyclovir